Composition for the prevention and/or treatment of the cytotoxic effects induced by the use of immunosuppressive agents

Abstract

A composition is disclosed which is suitable for the prevention and/or treatment of cell and tissue abnormalities of exogenous, toxic or metabolic origin and suitable for reducing the toxic effects of cyclosporin-A and other immunosuppressive agents, which may take the form of a food supplement or of an actual medicine, containing as its active ingredients in combination or separately packaged: (a) propionyl L-carnitine or one of its pharmacologically acceptable salts, and (b) an amino acid selected from the group consisting of glycine, serine, alanine and arginine, or mixtures thereof.

1. A combination composition consisting of:
 (a) propionyl L-carnitine or a pharmacologically acceptable salt thereof; and 
 (b) an amino acid selected from the group consisting of glycine, alanine, arginine and serine or the pharmacologically acceptable salts thereof or mixtures thereof 
 
       wherein the weight ratio (a):(b) ranges from 10:1 to 1:10. 
     
     
       2. A combination composition consisting of:
 (a) propionyl L-carnitine or a pharmacologically acceptable salt thereof and a carnitine selected from the group consisting of L-carnitine, valeryl L-carnitine, isovaleryl L-carnitine and butyryl L-carnitine or their pharmacologically acceptable salts or mixtures thereof; and 
 (b) an amino acid selected from the group consisting of glycine, alanine, arginine and serine or the pharmacologically acceptable salts thereof or mixtures thereof 
 
       wherein the weight ratio (a):(b) ranges from 10:1 to 1:10. 
     
     
       3. The composition of  claim 1 , wherein the weight ratio (a):(b) ranges from 5:1 to 1:5. 
     
     
       4. The composition of  claim 1  wherein the pharmacologically acceptable salt is selected from the group consisting of: chloride; bromide; iodide; aspartate, acid aspartate; citrate, acid citrate; tartrate; phosphate, acid phosphate; fumarate, acid fumarate; glycerophosphate; glucose phosphate; lactate; maleate, acid maleate; mucate; orotate; oxalate; acid oxalate; sulphate, acid sulphate; trichloroacetate; trifluoroacetate and methane suiphonate. 
     
     
       5. The composition of  claim 1 , orally administrable, in the form of a dietary supplement. 
     
     
       6. The composition of  claim 1 , orally, parenterally, rectally, sublingually or transdermally administrable, in the form of a medicament. 
     
     
       7. A method for treating cellular and tissue alterations due to the toxic effects of immunosuppressants which comprises administering to a subject in need thereof a combination composition of  claim 1 . 
     
     
       8. The method of  claim 7  wherein the immunosuppressants are selected from the group consisting of cyclosporin-A and tacrolimus. 
     
     
       9. The composition of  claim 1  as a dietary supplement in solid, semisolid or liquid form. 
     
     
       10. The composition of  claim 1 , in solid, semi-solid or liquid form. 
     
     
       11. The dietary supplement of  claim 9 , in the form of tablets, lozenges, pills, capsules, granulates or syrups. 
     
     
       12. The composition of  claim 10 , in the form of tablets, lozenges, pills, capsules, granulates, syrups, vials or drops. 
     
     
       13. A method for the treatment of nephrotoxic, vasculotoxic or cytotoxic lesions brought about by the use of immunosuppressants selected from the group consisting of cyclosporin-A and tacrolimus, which comprises administering to a subject in need thereof a combination composition of  claim 1 . 
     
     
       14. A method for treating cellular and tissue alterations of exogenous, toxic or metabolic origin and decreasing the toxic effects of immunosuppressants which comprises administering to a subject in need thereof a combination composition of  claim 1 . 
     
     
       15. A method for the treatment of nephrotoxic, vasculotoxic or cytotoxic lesions brought about by the use of immunosuppressants selected from the group consisting of cyclosporin-A and tacrolimus, which comprises administering to a subject in need thereof a combination composition of  claim 1 , 
       wherein the weight ratio of (a):(b) is 1:1. 
     
     
       16. A method for treating cellular and tissue alterations of exogenous, toxic or metabolic origin and decreasing the toxic effects of immunosuppressants which comprises administering to a subject in need thereof a combination composition of  claim 1 , 
       wherein the weight ratio of (a):(b) is 1:1. 
     
     
       17. A combination composition consisting of:
 (a) propionyl L-carnitine or a pharmacologically acceptable salt thereof; and 
 (b) an amino acid selected from the group consisting of glycine, alanine, arginine and serine or the pharmacologically acceptable salts thereof or mixtures thereof; and 
 (c) vitamins, coenzymes, mineral substances, aminoacids or antioxidants 
 
       wherein the weight ratio (a):(b) ranges from 10:1 to 1:10. 
     
     
       18. A method for the treatment of nephrotoxic lesions brought about by the use of immunosuppressants selected from the group consisting of cyclosporin-A and tacrolimus, which comprises administering to a subject in need thereof a combination composition of  claim 1 .